A person with spinal injuries today went down in history as the first to receive a treatment derived from human embryonic stem cells (hESCs).
Many people have already been treated with stem cells originating from adult tissue, such as bone marrow, but the trial is the first authorised attempt to treat someone with cells derived from hESCs, the cells in embryos that can grow into all tissues of the body.
Anti-abortion groups oppose such treatments because hESCs can usually be obtained only by destroying a human embryo. But backers point out that the cells have enormous potential for treating disease and regenerating tissue.
Following endless setbacks and delays in authorising the trial, the patient was treated at the Shepherd Center in Atlanta, Georgia.
Surgeons injected millions of oligodendrocyte progenitor cells grown from hESCs into the injury site through a fine needle, hoping the cells would stimulate nerve growth and re-sheathe nerves damaged through the injury. Injured rats treated with the cells recovered some mobility about a month after being treated.
Safety first
The hope is that these progenitor cells, codenamed GRNOPC1 cells, will help the patient overcome paralysis resulting from the injury, although the primary objective of the trial is to make sure the treatment is safe.
"Initiating the GRNOPC1 clinical trial is a milestone for the field of hESC-based therapies," said Thomas Okarma, president of Geron in Menlo Park, California, the company which has spent more than a decade developing treatments derived from hESCs.
Although the trial first received the go-ahead in January last year, it was put on hold the following August by the US Food and Drug Administration, which demanded further evidence that the treatment wouldn't cause cysts like those seen in some animal studies.
Approval was re-issued last August, and the patient whose treatment was announced today is the first to be treated in the seven-centre trial. A spokeswoman at the Shepherd Center said that all details of the person are being kept confidential for now, including their gender and age, and how the injury occurred.
Morale boost
Other stem-cell researchers hailed the news. "This is a significant milestone in our journey towards the promise of stem-cell-based medicines," says Ben Sykes, executive director of the UK National Stem Cell Network. "The global stem-cell and regenerative medicine community will be awaiting the results of this safety trial with much anticipation."
"This is very exciting news," says Ian Wilmut of the University of Edinburgh, UK, and creator of Dolly the cloned sheep. "However, it's very important to appreciate that the objective of trials at this stage is first of all [to ensure] that no harm is done to the patients."
"This first-in-man study marks the dawn of the 'stem-cell age'," says Chris Mason, professor of regenerative medicine at University College London. "This pivotal clinical trial is a major morale boost for scientists, clinicians and, most of all, for patients."
News of the trial is also likely to raise the morale of federally funded researchers at the US National Institutes of Health working on hESCs, as the legality of federal funding for their research is being challenged in court. In August, federally funded work on stem cells was temporarily suspended after a judge ruled that work on hESCs violates a legal amendment in 1995 forbidding funding of any experiments that involve destruction of human embryos.
The injunction was lifted a fortnight later, but only as a temporary measureuntil the legality of federal funding is resolved once and for all either in a court case or by altering the 1995 amendment.
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